Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Shell Fissure

Research Inc3,000 enrolled

Overview

This prospective implant-surveillance cohort will evaluate predictors of breast implant shell fissure. Women with aesthetic implants without baseline fissure or rupture will undergo annual clinical and imaging assessment for up to five years. Implant age, pocket plane, incision route, surface texture, and volume will be evaluated as predictors. The primary outcome is time to first confirmed focal shell fissure; progression to complete rupture, symptoms, inter-reader agreement, and revision will also be assessed.

A locked radiologic and operative definition will distinguish focal shell fissure from complete rupture, deformation, porosity, and leakage. Eligible women will enter only after baseline imaging shows no shell defect. Annual ultrasound and confirmatory MRI will prospectively identify incident events, which will undergo central blinded review and surgical confirmation when available. Delayed-entry time-to-event models will evaluate implant and surgical predictors and will account for bilateral implants and competing removal. A multi-state analysis will explore progression from intact implant to fissure and rupture if the event count is adequate.

Study Type

OBSERVATIONAL

Enrollment

3,000

Conditions

Breast Implant Complication Breast Implant Shell Defect

Interventions

Structured Implant Shell ImagingDIAGNOSTIC_TEST

Annual high-resolution ultrasound and confirmatory MRI will apply a locked definition of focal shell fissure, complete rupture, deformation, porosity, and silicone leakage. Event images will undergo blinded central review. Linked arm/group(s): Implant Shell Integrity Surveillance Cohort.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female sex and age 18 years or older. * Aesthetic breast implant with known implantation date or year and known pocket plane, incision route, surface texture, and volume. * No fissure or rupture identified by the baseline imaging algorithm. * Ability to undergo annual ultrasound and confirmatory MRI when indicated. * Written informed consent. Exclusion Criteria: * Confirmed fissure or rupture at cohort entry. * Reconstructive breast implantation or tissue expander. * Immediate planned implant removal or exchange. * Missing core implant characteristics. * MRI contraindication when MRI is required to adjudicate a suspected event. * Recalled/PIP implant if excluded by the final analytic plan.

Outcomes

Primary Outcomes

Time to First Confirmed Breast Implant Shell Fissure

Implant-level time from cohort entry to the first focal partial-thickness or noncomplete shell discontinuity meeting the locked MRI, ultrasound, or operative criteria and not meeting the definition of complete rupture.

Time frame: From cohort entry through years of prospective follow-up. 10 years

Secondary Outcomes

Fissure-Free Survival by Implant Age

Probability of remaining free of confirmed fissure at prespecified implant ages using delayed-entry survival methods.

Time frame: 10 years